Abstract
PreviewThis document specifies the procedure for the assessment of medical devices and their constituent materials with regard to their potential to induce skin sensitization.
This document includes:
— details of in vivo skin sensitization test procedures;
— key factors for the interpretation of the results.
NOTE Instructions for the preparation of materials specifically in relation to the above tests are given in Annex A.
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Status: PublishedPublication date: 2021-11
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Edition: 4Number of pages: 48
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- ICS :
- 11.100.20 Biological evaluation of medical devices
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| Format | Language | |
|---|---|---|
| std 1 166 | PDF + ePub | |
| std 2 166 | Paper |
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